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Completed

NCT Number: NCT00222937

Voice Therapy for Teachers With Voice Problems

The study compares two different forms of voice therapy, Lessac-Madsen Resonant Voice Therapy and Casper-Based Confidential Flow Therapy. The target population are teachers because they have the highest risk for developing voice problems. For this study the investigators are primarily interested in seeing if Lessac-Madsen Resonant Voice Therapy (LMRVT) and Casper-Based Confidential Flow Therapy (CBCFT) are equally effective at improving vocal functioning in teachers with phonotrauma, as assessed by the Voice Handicap Index (VHI).

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Massachusetts Eye & Ear Infirmary, Voice and Speech Laboratory, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Full or part time teacher including college professor, daycare and preschool
  • 21 years of age and older
  • Complaints of voice problems declared to be lasting continuously for one month or more
  • Any structural or functional change to the larynx that appears related to phonation,including bilateral or unilateral lesions (assuming normal overlying epithelium based on clinical examination), non-specific edema, or erythema that appear by clinical history related to phonation, or primary muscle tension dysphonia or other condition related to phonation without lesions
  • No concurrent ear, nose and/or throat diagnoses, e.g. acute allergies, except for chronic allergies, sinusitis, and laryngopharyngeal reflux disease (LPR)
  • No vocal fold hemorrhage
  • No known degenerative medical conditions (e.g., degenerative neuromuscular disease, malignant process undergoing treatment or with less than 5 years remission, uncontrolled systemic disease (e.g., auto immune disease, or hormonal condition)
  • Normal hearing to 30 dB at 1000Hz - 3000Hz in the better ear
  • The participant is able to start therapy within 6 weeks of the initial evaluation and can be scheduled for 8 sessions (two per visit) in a 6-week time period
  • Agreement by the participant to provide information regarding days missed from work during the previous year and the year following treatment

Exclusion criteria

  • Known degenerative medical condition
  • Concurrent ear-nose-throat diagnosis, e.g., acute allergies (but chronic allergies, sinusitis, and laryngopharyngeal reflux disease (LPR) are not exclusion criteria) and vocal fold hemorrhage
  • Degenerative medical conditions that would exclude a participant from participation include, but are not limited to: degenerative neuromuscular disease, malignant process undergoing treatment or with less than 5 years remission, uncontrolled systemic disease (e.g. auto immune disease), or hormonal condition.

Treatment and study plan

Lessac-Madsen Resonant Voice Therapy

Behavioral

Patients receive 8 sessions of therapy over a course of 4 weeks, with one double session per week.

Casper-Based Confidential Flow Therapy

Behavioral

Patients receive 8 sessions of therapy over a course of 4 weeks, with one double session per week.

Primary outcomes

  1. Score on Voice Handicap Index (VHI)

    Time frame: one year

Secondary outcomes

  1. Does LMRVT contribute to the actual acquisition of "resonant voice" in speech?

    Time frame: one year

  2. Do LMRVT or CBCFT improve laryngeal appearance?

    Time frame: one year

  3. Do LMRVT or CBCFT improve conversational voice quality?

    Time frame: one year

  4. Do LMRVT or CBCFT reduce the occurrence of laryngeal microsurgery?

    Time frame: one year

  5. Do LMRVT or CBCFT reduce the number of workdays lost annually?

    Time frame: one year

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

Efficacy of Voice Therapy for Phonotrauma in Teachers

Important dates

Study start
2005
Primary completion
2009
Study completion
2010
First posted
Sep 22, 2005
Registry last updated
Jan 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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